Exclusion of pregnant and lactating women from COVID-19 vaccine trials: a missed opportunity.
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ABSTRACT:
SUBMITTER: Van Spall HGC
PROVIDER: S-EPMC7989536 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The rapid development and roll-out of coronavirus disease 2019 (COVID-19) vaccines is providing hope for a way to control the pandemic. As pregnant and lactating women are generally excluded from clinical trials, the vaccination programme was launched without adequate safety and efficacy data for pregnant women. Yet many professional organizations have recognized the need for administration of COVID-19 vaccines in pregnancy and have issued their own set of recommendations. The lack of evidence, however, has often led to confused messaging, inconsistent language and differing recommendations across organizations, potentially contributing to delay or refusal to accept vaccination by pregnant women. We summarize those differences and recommend that leaders collaborate at a country level to produce joint recommendations. We use the example of Australia, where two professional authorities along with the government and partners in New Zealand worked towards one message, consistent language and a unified recommendation. The aim was to help health professionals and women who are planning pregnancy or who are currently pregnant or breastfeeding to make an informed decision about COVID-19 vaccination. National advisory groups for immunization, professional obstetric organizations and government bodies should be encouraged to coordinate their statements on COVID-19 vaccination for pregnant and lactating women and to use similar language and phrasing for greater clarity.
| S-EPMC8477428 | biostudies-literature
Project description:COVID-19 vaccines are an effective public health intervention to reduce COVID-19-related morbidity and mortality. Given that pregnant and lactating women have a higher risk of severe COVID-19 complications, it is paramount to understand the factors that inform vaccine decision-making among this population. In this study, we sought to identify facilitators and barriers to COVID-19 vaccine acceptance and vaccine promotion in pregnant and lactating women in Bangladesh. We conducted 40 in-depth interviews with 12 pregnant women, 12 lactating women, and 16 health workers from one urban and four rural communities in Bangladesh. We used a grounded theory approach to identify emerging themes. Our results suggest that health workers and religious leaders played key roles in promoting COVID-19 vaccines in this population. Further, we found that the culture of trust in public health authorities and the existing vaccine infrastructure facilitated vaccine promotion. However, changes in vaccine eligibility and myths and rumors acted as both facilitators and barriers to vaccine promotion within our study. It is crucial that maternal immunization vaccine promotion efforts push pregnant and lactating women toward vaccine acceptance to protect the health of mothers and their babies. Additionally, as new maternal vaccines are developed and licensed, understanding how to best promote vaccines within this group is paramount.
| S-EPMC10459640 | biostudies-literature
Project description:The acceleration of climatic, digital, and health challenges is testing scientific communities. Scientists must provide concrete answers in terms of technological solutions to a society which expects immediate returns on the public investment. We are living such a scenario on a global scale with the pandemic crisis of COVID-19 where expectations for virological and serological diagnosis tests have been and are still gigantic. In this Perspective, we focus on a class of biosensors (mechanical biosensors) which are ubiquitous in the literature in the form of high performance, sensitive, selective, low-cost biological analysis systems. The spectacular development announced in their performance in the last 20 years suggested the possibility of finding these mechanical sensors on the front line of COVID-19, but the reality was quite different. We analyze the cause of this rendez-vous manqué, the operational criteria that kept these biosensors away from the field, and we indicate the pitfalls to avoid in the future in the development of all types of biosensors of which the ultimate goal is to be immediately operational for the intended application.
| S-EPMC7574628 | biostudies-literature
Project description:ImportancePregnant women are at increased risk of morbidity and mortality from COVID-19 but have been excluded from the phase 3 COVID-19 vaccine trials. Data on vaccine safety and immunogenicity in these populations are therefore limited.ObjectiveTo evaluate the immunogenicity of COVID-19 messenger RNA (mRNA) vaccines in pregnant and lactating women, including against emerging SARS-CoV-2 variants of concern.Design, setting, and participantsAn exploratory, descriptive, prospective cohort study enrolled 103 women who received a COVID-19 vaccine from December 2020 through March 2021 and 28 women who had confirmed SARS-CoV-2 infection from April 2020 through March 2021 (the last follow-up date was March 26, 2021). This study enrolled 30 pregnant, 16 lactating, and 57 neither pregnant nor lactating women who received either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines and 22 pregnant and 6 nonpregnant unvaccinated women with SARS-CoV-2 infection.Main outcomes and measuresSARS-CoV-2 receptor binding domain binding, neutralizing, and functional nonneutralizing antibody responses from pregnant, lactating, and nonpregnant women were assessed following vaccination. Spike-specific T-cell responses were evaluated using IFN-γ enzyme-linked immunospot and multiparameter intracellular cytokine-staining assays. Humoral and cellular immune responses were determined against the original SARS-CoV-2 USA-WA1/2020 strain as well as against the B.1.1.7 and B.1.351 variants.ResultsThis study enrolled 103 women aged 18 to 45 years (66% non-Hispanic White) who received a COVID-19 mRNA vaccine. After the second vaccine dose, fever was reported in 4 pregnant women (14%; SD, 6%), 7 lactating women (44%; SD, 12%), and 27 nonpregnant women (52%; SD, 7%). Binding, neutralizing, and functional nonneutralizing antibody responses as well as CD4 and CD8 T-cell responses were present in pregnant, lactating, and nonpregnant women following vaccination. Binding and neutralizing antibodies were also observed in infant cord blood and breast milk. Binding and neutralizing antibody titers against the SARS-CoV-2 B.1.1.7 and B.1.351 variants of concern were reduced, but T-cell responses were preserved against viral variants.Conclusion and relevanceIn this exploratory analysis of a convenience sample, receipt of a COVID-19 mRNA vaccine was immunogenic in pregnant women, and vaccine-elicited antibodies were transported to infant cord blood and breast milk. Pregnant and nonpregnant women who were vaccinated developed cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants of concern.
| S-EPMC8120446 | biostudies-literature
Project description:Antivirals have demonstrated efficacy in treating other infectious diseases in early stages of disease, reducing morbidity, mortality, and the likelihood of onward transmission. At the time of writing, more than 1900 clinical trials are registered globally to assess the efficacy and safety of candidate therapeutics for COVID-19. The majority of these trials are designed to evaluate the comparative efficacy and safety of candidate therapeutics for the treatment of COVID-19 to prevent death among populations of hospitalized patients with advanced disease. Yet, emerging epidemiological evidence now indicates that the majority of those infected with the SARS-CoV-2, while still infectious, experience minimal or mild disease symptomology. Like HIV and hepatitis C that pioneered treatment as prevention, there is a missed opportunity for trials of early pharmaceutical intervention for COVID-19 disease evaluating not only reductions in morbidity and mortality but also transmissibility. We discuss this clinical research gap within an historical context of viral treatment as prevention for HIV and hepatitis C, and comment on the challenges and opportunities for clinical research of candidate therapeutics for early COVID-19 disease.
| S-EPMC7553378 | biostudies-literature
Project description:BackgroundAlthough emerging data during the SARS-CoV-2 pandemic have demonstrated robust messenger RNA vaccine-induced immunogenicity across populations, including pregnant and lactating individuals, the rapid waning of vaccine-induced immunity and the emergence of variants of concern motivated the use of messenger RNA vaccine booster doses. Whether all populations, including pregnant and lactating individuals, will mount a comparable response to a booster dose is not known.ObjectiveThis study aimed to profile the humoral immune response to a COVID-19 messenger RNA booster dose in a cohort of pregnant, lactating, and nonpregnant age-matched women.Study designThis study characterized the antibody response against ancestral Spike and Omicron in a cohort of 31 pregnant, 12 lactating, and 20 nonpregnant age-matched controls who received a BNT162b2 or messenger RNA-1273 booster dose after primary COVID-19 vaccination. In addition, this study examined the vaccine-induced antibody profiles of 15 maternal-to-cord dyads at delivery.ResultsReceiving a booster dose during pregnancy resulted in increased immunoglobulin G1 levels against Omicron Spike (postprimary vaccination vs postbooster dose; P=.03). Pregnant and lactating individuals exhibited equivalent Spike-specific total immunoglobulin G1, immunoglobulin M, and immunoglobulin A levels and neutralizing titers against Omicron compared with nonpregnant women. Subtle differences in Fc receptor binding and antibody subclass profiles were observed in the immune response to a booster dose in pregnant vs nonpregnant individuals. The analysis of maternal and cord antibody profiles at delivery demonstrated equivalent total Spike-specific immunoglobulin G1 in maternal and cord blood, yet higher Spike-specific FcγR3a-binding antibodies in the cord relative to maternal blood (P=.002), consistent with the preferential transfer of highly functional immunoglobulin. Spike-specific immunoglobulin G1 levels in the cord were positively correlated with the time elapsed since receiving the booster dose (Spearman R, .574; P=.035).ConclusionStudy data suggested that receiving a booster dose during pregnancy induces a robust Spike-specific humoral immune response, including against Omicron. If boosting occurs in the third trimester of pregnancy, higher Spike-specific cord immunoglobulin G1 levels are achieved with greater time elapsed between receiving the booster and delivery. Receiving a booster dose has the potential to augment maternal and neonatal immunity.
| S-EPMC9295313 | biostudies-literature
Project description:Pregnant women are at higher risk of developing severe COVID-19 symptoms. Therefore, booster dose against COVID-19 was recommended for this special population in Jordan. However, vaccine hesitancy/refusal remains the main obstacle to providing immunity against the spread of COVID-19. Thus, the aim of this study is to examine the intention of pregnant/planning to get pregnant and lactating women towards receiving a booster dose against COVID-19 and its associated factors. A questionnaire was given to Jordanian pregnant/planning to get pregnant and lactating females. A total of 695 females were enrolled in the study. Older age, having a chronic disease, high education, high income, and high perceived risk of COVID-19 were significantly associated with higher knowledge about COVID-19. High perceived risk of COVID-19 was significantly associated with better practice. Participants who anticipated they might contract COVID-19 in the next six months, had high perceived risk of COVID-19, had high knowledge, had received the COVID-19 vaccine based on conviction, and smokers had higher intention to receive a booster dose of the COVID-19 vaccination. In order to increase pregnant and lactating women's intention to receive a booster dose of the COVID-19 vaccine, public health organizations should consider developing comprehensive health education campaigns.
| S-EPMC10383860 | biostudies-literature
Project description:Substantial immunological changes occur throughout pregnancy to render the mother immunologically tolerant to the fetus and allow fetal growth. However, additional local and systemic immunological adaptations also occur, allowing the maternal immune system to continue to protect the dyad against pathogens both during pregnancy and after birth through lactation. This fine balance of tolerance and immunity, along with physiological and hormonal changes, contributes to increased susceptibility to particular infections in pregnancy, including more severe coronavirus disease 2019 (COVID-19). Whether these changes also make pregnant women less responsive to vaccination or induce altered immune responses to vaccination remains incompletely understood. To define potential changes in vaccine response during pregnancy and lactation, we undertook deep sequencing of the humoral vaccine response in a group of pregnant and lactating women and nonpregnant age-matched controls. Vaccine-specific titers were comparable between pregnant women, lactating women, and nonpregnant controls. However, Fc receptor (FcR) binding and antibody effector functions were induced with delayed kinetics in both pregnant and lactating women compared with nonpregnant women after the first vaccine dose, which normalized after the second dose. Vaccine boosting resulted in high FcR-binding titers in breastmilk. These data suggest that pregnancy promotes resistance to generating proinflammatory antibodies and indicates that there is a critical need to follow prime-boost timelines in this vulnerable population to ensure full immunity is attained.
| S-EPMC9067624 | biostudies-literature
Project description:BackgroundPregnant and lactating women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking.ObjectiveThis study aimed to evaluate the immunogenicity and reactogenicity of coronavirus disease 2019 messenger RNA vaccination in pregnant and lactating women compared with: (1) nonpregnant controls and (2) natural coronavirus disease 2019 infection in pregnancy.Study designA total of 131 reproductive-age vaccine recipients (84 pregnant, 31 lactating, and 16 nonpregnant women) were enrolled in a prospective cohort study at 2 academic medical centers. Titers of severe acute respiratory syndrome coronavirus 2 spike and receptor-binding domain immunoglobulin G, immunoglobulin A, and immunoglobulin M were quantified in participant sera (n=131) and breastmilk (n=31) at baseline, at the second vaccine dose, at 2 to 6 weeks after the second vaccine, and at delivery by Luminex. Umbilical cord sera (n=10) titers were assessed at delivery. Titers were compared with those of pregnant women 4 to 12 weeks from the natural infection (n=37) by enzyme-linked immunosorbent assay. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of women who delivered during the study period. Postvaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed-effects model, with correction for multiple comparisons, were used to assess differences among groups.ResultsVaccine-induced antibody titers were equivalent in pregnant and lactating compared with nonpregnant women (pregnant, median, 5.59; interquartile range, 4.68-5.89; lactating, median, 5.74; interquartile range, 5.06-6.22; nonpregnant, median, 5.62; interquartile range, 4.77-5.98, P=.24). All titers were significantly higher than those induced by severe acute respiratory syndrome coronavirus 2 infection during pregnancy (P<.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord than maternal sera, although this finding did not achieve statistical significance (maternal sera, median, 104.7; interquartile range, 61.2-188.2; cord sera, median, 52.3; interquartile range, 11.7-69.6; P=.05). The second vaccine dose (boost dose) increased severe acute respiratory syndrome coronavirus 2-specific immunoglobulin G, but not immunoglobulin A, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups.ConclusionCoronavirus disease 2019 messenger RNA vaccines generated robust humoral immunity in pregnant and lactating women, with immunogenicity and reactogenicity similar to that observed in nonpregnant women. Vaccine-induced immune responses were statistically significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.
| S-EPMC7997025 | biostudies-literature
Project description:BackgroundAlthough mass vaccination against COVID-19 may prove to be the most efficacious end to this deadly pandemic, there remain concern and indecision among the public toward vaccination. Because pregnant and reproductive-aged women account for a large proportion of the population with particular concerns regarding vaccination against COVID-19, this survey aimed at investigating their current attitudes and beliefs within our own institution.ObjectiveThis study aimed to understand vaccine acceptability among pregnant, nonpregnant, and breastfeeding respondents and elucidate factors associated with COVID-19 vaccine acceptance.Study designWe administered an anonymous online survey to all women (including patients, providers, and staff) at our institution assessing rates of acceptance of COVID-19 vaccination. Respondents were contacted in 1 of 3 ways: by email, advertisement flyers, and distribution of quick response codes at virtual town halls regarding the COVID-19 vaccine. Based on their responses, respondents were divided into 3 mutually exclusive groups: (1) nonpregnant respondents, (2) pregnant respondents, and (3) breastfeeding respondents. The primary outcome was acceptance of vaccination. Prevalence ratios were calculated to ascertain the independent effects of multiple patient-level factors on vaccine acceptability.ResultsThe survey was administered from January 7, 2021, to January 29, 2021, with 1012 respondents of whom 466 (46.9%) identified as non-Hispanic White, 108 (10.9%) as non-Hispanic Black, 286 (28.8%) as Hispanic, and 82 (8.2%) as non-Hispanic Asian. The median age was 36 years (interquartile range, 25-47 years). Of all the respondents, 656 respondents (64.8%) were nonpregnant, 216 (21.3%) were pregnant, and 122 (12.1%) were breastfeeding. There was no difference in chronic comorbidities when evaluated as a composite variable (Table 1). A total of 390 respondents (39.2%) reported working in healthcare. Nonpregnant respondents were most likely to accept vaccination (457 respondents, 76.2%; P<.001) with breastfeeding respondents the second most likely (55.2%). Pregnant respondents had the lowest rate of vaccine acceptance (44.3%; P<.001). Prevalence ratios revealed all non-White races except for non-Hispanic Asian respondents, and Spanish-speaking respondents were less likely to accept vaccination (Table 3). Working in healthcare was not found to be associated with vaccine acceptance among our cohort.ConclusionIn this survey study of only women at a single institution, pregnant respondents of non-White or non-Asian races were more likely to decline vaccination than nonpregnant and breastfeeding respondents. Working in healthcare was not associated with vaccine acceptance.
| S-EPMC8146275 | biostudies-literature